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Sunday, May 25, 2008

In March of this year, the GAO warned that the EPA's IRIS (Integrated Risk Information System) database was at risk of becoming obsolete because the EPA is buried under pending assessments of threats posed by chemicals present in the environment. When I say it is buried, that is almost an understatement. In fiscal years 2006 and 2007, a total of four assessments were completed of thirty two submitted over the same period of time. Currently, over seventy assessments are pending. [The chart below, found on p.7 of the report illustrates the increase in the backlog and the decrease in completion of reporting.]

EPA’s new process expressly defines such comments as “deliberative” and excludes them from the public record. GAO continues to believe that it is critical that input from all parties—particularly agencies that may be affected by the outcome of IRIS assessments—be publicly available. In addition, the estimated time frames under the new process, especially for chemicals of key concern, will likely perpetuate the cycle of delays to which the majority of ongoing assessments have been subject. Instead of significantly streamlining the process, which GAO recommended, EPA has institutionalized a process that from the outset is estimated to take 6 to 8 years to complete. This is problematic because of the substantial rework such cases often require to take into account changing science and methodologies. Since EPA’s new process is not responsive to GAO’s recommendations, the viability of this critical database has been further jeopardized. [p.2]

Another change keeps comments from other federal agencies on assessments out of the public record.

It is important that the comments of other agencies be included in the public record because although IRIS assessments are not by nature regulatory, quantitative IRIS values are one of the data points considered when risk-management decisions are made and therefore they serve as a benchmark of regulatory consideration.

This process is obstructed by the fact that the completion process for assessments is so dismal. Because of the staggering backlog, the EPA has been unable to complete assessments of key chemicals that are in the forefront of public health concern for their known health risks, including carcinogenic and mutagenic properties. Chemicals awaiting formal assessment include known offenders like trichloroethylene (TCE), naphthalene, tetrachloroethylene, dioxin, and formaldehyde.

And just when you thought that the process was just about manipulated to the max - they manage to throw one more spanner in the works - unlike every other department in FDA and pretty much all departments across all agencies of the federal government - there is no timeline for completion of assessments.

IRIS was put in place in 1985 to increase constituent confidence in the agency and the governments ability to protect it's citizens, after high-profile chemical contamination cases led to the abandonment of first Love Canal, New York in 1981, and then Times Beach, Missouri in 1985. The database was conceived of as a sort of clearing house for information on toxic chemicals.

Its importance has increased over time as EPA program offices and the states have increasingly relied on IRIS information in making environmental protection decisions. Currently, the IRIS database contains assessments of more than 540 chemicals. According to EPA, national and international users access the IRIS database approximately 9 million times a year. EPA’s Assistant Administrator for the Office of Research and Development has described IRIS as the premier national and international source for qualitative and quantitative chemical risk information; other federal agencies have noted that IRIS data are widely accepted by all levels of government across the country for application of public health policy, providing benefits such as uniform, standardized methods for toxicology testing and risk assessment, as well as uniform toxicity values. Similarly, a private-sector risk assessment expert has stated that the IRIS database has become the most important source of regulatory toxicity values for use across EPA’s programs and is also widely used across state programs and internationally.

Historically and currently, the focus of IRIS toxicity assessments has been on the potential health effects of long-term (chronic) exposure to chemicals. According to OMB, EPA is the only federal agency that develops qualitative and quantitative assessments of both cancer and noncancer risks of exposure to chemicals, and EPA does so largely under the IRIS program. [p.3]

When the GAO revisited the system changes that the EPA announced in April, they discovered that the new tweaks were actually counterproductive. The new requirement that OMB review assessments contributes to the backlog - assessments completed by the EPA essentially stnd on line awaiting OMB approval before they are released. And every single delay presents the distinct possibility that the entire process will have to be started over again as methodologies and best practices advance.

Further, because EPA staff time continues to be dedicated to completing assessments in the backlog, EPA’s ability to both keep the more than 540 existing assessments up to date and initiate new assessments is limited. Importantly, EPA program offices and state and local entities have requested assessments of hundreds of chemicals not yet in IRIS, and EPA data as of 2003 indicated that the assessments of 287 chemicals in the database may be outdated—that is, new information could change the risk estimates currently in IRIS or enable EPA to develop additional risk estimates for chemicals in the database (for example, developing a cancer potency estimate for assessments with only noncancer estimates). In addition, because EPA’s 2003 data are now more than 4 years old, it is likely that more assessments may be outdated now.

The consequences of not having current, credible IRIS information can be significant. EPA’s inability to complete its assessment of formaldehyde, which the agency initiated in 1997 to update information already in IRIS on the chemical, has had a significant impact on EPA’s air toxics program. Although in 2003 and 2004, the National Cancer Institute and the National Institute of Occupational Safety and Health (NIOSH) had released updates to major epidemiological studies of industrial workers that showed a relationship between formaldehyde and certain cancers, including leukemia, EPA did not move forward to finalize an IRIS assessment incorporating these important data. Instead, EPA opted to await the results of another update to the National Cancer Institute study. While this additional research was originally estimated to take, at most, 18 months to complete, at the time of our report (more than 3 years later) the update was not complete. In the absence of this information, EPA’s Office of Air and Radiation decided to use risk information developed by an industry-funded organization—the CIIT Centers for Health Research—for a national emissions standard. This decision was a factor in EPA exempting certain facilities with formaldehyde emissions from the national emissions standard.[p.7-8]

Yes -you caught that right. Data from a study funded by the chemical industry was used to formulate the assessment of health risk for formaldehyde. The mind boggles...

Actually, what they have done by intent is what has occurred by accident and derailed a thousand promising research projects. I spent a big part of my career in research labs, and we have a name for the phenomenon they have employed by design. We call it "paralysis by analysis."

The EPA is yet another federal agency that has been crippled and undermined, kept from completing it's mission, and the detriment of the agency has served to the benefit a select few who have been allowed to operate under outdated assessments and continue polluting at unsafe rates.

The next president needs an EPA chief with a strong background in toxicology and environmental sciences. And the balls to stand up to gigantic, polluting corporations who perceive the best interest of human beings - especially poor and powerless ones - to be diametrically opposed to their own.

The next person to head up the EPA will be tackling a thankless job, and have to do battle every day - but battle he or she must, because the job they will be tasked with will have an impact on the quality of life and health of future generations for the foreseeable future.

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